- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03636581
Lifestyle Intervention Program in Overweight Medical Students
January 14, 2022 updated by: Joanne DiFrancisco-Donoghue, New York Institute of Technology
A Novel Lifestyle Intervention Program to Improve Body Composition and Chronic Disease Bio Markers in Overweight Medical Students: a Randomized Cross-over Trial
This study will be a randomized cross-over design over the course of 2 academic years.
40 subjects -20 overweight women and 20 over weight men will be recruited.
Each subject will have body composition tested, blood lipid profile, and resting metabolic rate done in the beginning of the first academic year and at the end of the first academic year.
The intervention group will receive activity trackers, diet counseling, and fitness counseling for one academic year.
The second year, all outcome measures (a body scan, blood lipid profile, and resting metabolic rate) will be performed again at the start of the academic year 2, except the intervention group will now be the control group and the control group will now receive the same intervention.
All final outcome measures will be performed at the end of the second year.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Old Westbury, New York, United States, 11568
- New York Institute of Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female NYITCOM students between the ages of 18-35
- BMI ≥ 25.0
- Body fat % >19% for males; >33% for women (will be determined by body composition scan)
- Own their own smartphone
Exclusion Criteria:
- People who have used weight loss smartphone applications in the past 6 month
- People who have used an activity tracker in past 6 months
- Anyone who answers yes to one or more questions on the PAR-Q screen
- Any contraindication to having a duel x-ray body scan performed based on the American College of Radiology's practice guidelines
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
This group will receive a smart watch to track activity and diet.
This group will also receive education on nutrition and exercise.
|
This group will receive online education modules to educate them on exercise prescription, nutrition and behavioral changes.
|
No Intervention: Control
This group will receive a smart watch to track activity only with no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body fat percentage
Time Frame: 4 months
|
Body composition
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Step Count
Time Frame: 4 months
|
Activity based on step count
|
4 months
|
Resting Metabolic Rate
Time Frame: 4 months
|
Resting metabolic rate changes as per oxygen consumption
|
4 months
|
Total Cholesterol
Time Frame: 4 months
|
fasting serum mg/dL
|
4 months
|
High Density Lipoproteins
Time Frame: 4 months
|
fasting serum mg/dL
|
4 months
|
Low Density Lipoproteins
Time Frame: 4 months
|
fasting serum mg/dL
|
4 months
|
Triglycerides
Time Frame: 4 months
|
fasting serum mg/dL
|
4 months
|
Hemoglobin A1C
Time Frame: 4 months
|
fasting plasma % of total hemoglobin
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joanne Donoghue, New York Institute of Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2018
Primary Completion (Actual)
April 25, 2021
Study Completion (Actual)
April 25, 2021
Study Registration Dates
First Submitted
August 14, 2018
First Submitted That Met QC Criteria
August 14, 2018
First Posted (Actual)
August 17, 2018
Study Record Updates
Last Update Posted (Actual)
January 18, 2022
Last Update Submitted That Met QC Criteria
January 14, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BHS-1333
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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